FDA gives rare certification to LifeSouth cord blood program

In this Aug. 12, 2012 file photo, Rachel Booth, cell therapy specialist II, gets a sample of a human umbilical cord from a freezer at LifeSouth on Newberry Road in Gainesville. On Thursday, the Food and Drug Administration notified LifeSouth that its license for cord blood manufacturing has been approved.

Matt Stamey/The Gainesville Sun

By Caitlin SinettCorrespondent

Published: Friday, June 14, 2013 at 3:22 p.m.

Last Modified: Friday, June 14, 2013 at 3:22 p.m.

The Food and Drug Administration has approved LifeSouth Community Blood Center’s license to manufacture cord blood, making LifeCord, a program of LifeSouth, the fifth public cord blood bank in the country to receive an FDA license.

Dr. John R. Wingard, LifeCord’s medical director and a physician at UF Health Shands Hospital, said LifeSouth has been collecting cord blood for 15 years and has collected about 11,000 units of cord blood.

He said the blood has to go through rigorous testing to be allowed on any bone marrow registry. It must be screened for genetic diseases, infectious diseases, and there must be a sufficient number of cells so LifeSouth can make sure it provides the highest-quality product.

He said 5,000 units of cord blood from LifeSouth are listed on the bone marrow registry that can be used by clinicians around the world.

Wingard said that each year hundreds of lives are saved, mostly children, from cord blood transfusions.

The placenta and umbilical cord tissues are discarded. They are not needed for the health of the mother or baby, but they are a good source of stem cells.

“We can collect blood from that, and that can be used as a life-saving stem cell source,” Wingard said.

The blood that is collected can be transfused into people who have leukemia, lymphoma or another serious blood disease. The cord blood creates new cells.

The process of collecting the blood does not endanger the baby or the mother.

Nancy Eckert, LifeSouth’s CEO, said the process to get an FDA license started about 18 months ago.

She said the blood is frozen and that it can take a long time for a patient to be matched up with the right blood.

Eckert said the blood is dispersed to people all over the world. LifeSouth’s cord blood operation has been a joint effort between LifeSouth, the University of Florida and UF Health Shands Hospital.

Wingard said cord blood that cannot be used for transfusions is studied to see if it could be used for people with diabetes, or if stem cells can be given back to an infant to repair brain injury.

He said it’s a good example of how UF and Shands can pull together and work to serve a health need for the community — nationally and internationally

“The gift of that cord blood to another family to save the life of another child, that just makes it so much more,” Wingard said.

<p>The Food and Drug Administration has approved LifeSouth Community Blood Center's license to manufacture cord blood, making LifeCord, a program of LifeSouth, the fifth public cord blood bank in the country to receive an FDA license.</p><p>Dr. John R. Wingard, LifeCord's medical director and a physician at UF Health Shands Hospital, said LifeSouth has been collecting cord blood for 15 years and has collected about 11,000 units of cord blood.</p><p>He said the blood has to go through rigorous testing to be allowed on any bone marrow registry. It must be screened for genetic diseases, infectious diseases, and there must be a sufficient number of cells so LifeSouth can make sure it provides the highest-quality product.</p><p>He said 5,000 units of cord blood from LifeSouth are listed on the bone marrow registry that can be used by clinicians around the world.</p><p>Wingard said that each year hundreds of lives are saved, mostly children, from cord blood transfusions.</p><p>The placenta and umbilical cord tissues are discarded. They are not needed for the health of the mother or baby, but they are a good source of stem cells.</p><p>“We can collect blood from that, and that can be used as a life-saving stem cell source,” Wingard said.</p><p>The blood that is collected can be transfused into people who have leukemia, lymphoma or another serious blood disease. The cord blood creates new cells.</p><p>The process of collecting the blood does not endanger the baby or the mother.</p><p>Nancy Eckert, LifeSouth's CEO, said the process to get an FDA license started about 18 months ago.</p><p>She said the blood is frozen and that it can take a long time for a patient to be matched up with the right blood.</p><p>Eckert said the blood is dispersed to people all over the world. LifeSouth's cord blood operation has been a joint effort between LifeSouth, the University of Florida and UF Health Shands Hospital.</p><p>Wingard said cord blood that cannot be used for transfusions is studied to see if it could be used for people with diabetes, or if stem cells can be given back to an infant to repair brain injury.</p><p>He said it's a good example of how UF and Shands can pull together and work to serve a health need for the community — nationally and internationally</p><p>“The gift of that cord blood to another family to save the life of another child, that just makes it so much more,” Wingard said.</p>